Drug and Pharmaceutical Traceability

This week the House Committee on Energy and Commerce approved the Safeguarding America’s Pharmaceuticals Act of 2013 (H.R. 1919). The bill, if passed by Congress, would introduce a lot-level pedigree model for prescription drugs, for responsible handling and keeping track of shipments up and down the supply chain from manufacturer to pharmacist.

Currently, standards for the pharmaceutical distribution supply chain vary by state. This bill will establish a national standard of tracing requirements for manufacturers, wholesale distributors, pharmacies and packagers based on changes in ownership. It establishes a collaborative, transparent process between the Food and Drug Administration (FDA) and stakeholders to study ways to even further secure the pharmaceutical supply chain.

There are an estimated 4 billion prescriptions filled each year. When people take a prescribed medication they should have confidence that the medicine will not harm. Yet, counterfeit drug distribution is on the rise. Over the last year, the FDA has issued three warnings that counterfeits, including those for cancer patients, had infiltrated America’s pharmaceutical supply chain. To counter this epidemic, every drug manufacturer is required to serialize, bar code or RFID drug products at the item, case and pallet level to generate a pedigree document to track, trace and authenticate the product from the time it is initially sold to a distributor all the way through the supply chain to the point of distribution.

Lot-level traceability is commonly employed in the food industry. However, it has come under fire as a solution for pharma on the grounds that it does not go far enough to secure the supply chain. In particular for not setting a process in motion to extend the measures to include unit-level traceability of each medicine pack, as is mandated in the California electronic pedigree legislation which is due to come into effect in 2015. Any reconciled House and Senate bill would preempt California’s or any other state plans. Important provisions contained within this legislation include:

Establishing lot-level tracing requirements for manufacturers, wholesale distributors, pharmacies and packagers based on changes in ownership.

Requiring the affiliates of the supply chain, including third-party logistics providers to undertake verification and notification activities regarding suspect or illegitimate products.

Requiring members of the supply chain to only transact with registered or licensed entities.

At Appolis, we are serving the medical device and pharma communities with their compliance needs and concerns. Our WithoutWire™ intuitive technology will interface with your ERP Solution to provide real-time visibility within your walls and in your external supply chain. See more about the Art of Inventory at www.appolis.com